E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Giant Cell Tumour of Bone |
tumor de células gigantes del hueso. |
|
E.1.1.1 | Medical condition in easily understood language |
Tumour of Bone |
Tumor de hueso |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluate adverse events of interest in subjects with GCTB treated with denosumab in Study 20062004 |
Evaluar los acontecimientos adversos de interés en sujetos con TCGH tratados con denosumab en el estudio 20062004. |
|
E.2.2 | Secondary objectives of the trial |
Evaluate treatment-emergent adverse events for subjects who are receiving denosumab Evaluate serious adverse events for all subjects Summarize the rate of disease progression or recurrence of GCTB for all subjects Summarize the use of GCTB interventions for all subjects |
-Evaluar los acontecimientos adversos que aparecen durante el tratamiento en sujetos que reciben denosumab. -Evaluar los acontecimientos adversos graves en todos los sujetos. -Resumir la tasa de progresión o recurrencia de la enfermedad de TCGH en todos los sujetos. -Resumir el uso de intervenciones del TCGH en todos los sujetos. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subject is currently enrolled in Study 20062004. - Subject or subject’s legally acceptable representative has provided informed consent/assent prior to initiation of any study-specific activities/procedures. |
- Todos los sujetos del estudio 20062004 - Todos los sujetos que acepten participar en este estudio y firmen el ICF se considerarán incluidos. |
|
E.4 | Principal exclusion criteria |
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator’s knowledge. - Females of childbearing potential on denosumab and not willing to continue to use 1 highly effective method of contraception during treatment and for 5 months after the end of treatment. |
-Sujetos que no estén disponibles para completar todas las visitas o procedimientos del estudio requeridos por el protocolo y / o para cumplir con todos los procedimientos del estudio requeridos según el conocimiento del investigador. -Mujeres en edad fértil con denosumab y que no están dispuestas a seguir usando un método altamente eficaz de anticoncepción durante el tratamiento y durante los 5 meses posteriores al final del tratamiento. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Rate of adverse events of interest in subjects with GCTB treated with denosumab in Study 20062004 |
Tasa de acontecimientos adversos de interés en sujetos con TCGH tratados con denosumab en el estudio 20062004. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Throughout whole duration of study |
- Durante toda la duración del ensayo. |
|
E.5.2 | Secondary end point(s) |
Rate of treatment-emergent adverse events for subjects who are receiving denosumab Rate of serious adverse events for all subjects Rate of disease progression or recurrence of GCTB for all subjects Rate of GCTB interventions for all subjects |
-Tasa de acontecimientos adversos que aparecen durante el tratamiento en sujetos que reciben denosumab. -Tasa de acontecimientos adversos graves en todos los sujetos. -Tasa de progresión o recurrencia de la enfermedad de TCGH en todos los sujetos. -Tasa de intervenciones del TCGH en todos los sujetos. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Throughout whole duration of study |
- Durante toda la duración del ensayo. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Austria |
France |
Germany |
Italy |
Poland |
Spain |
Sweden |
United Kingdom |
United States |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The EOS date is defined as the date when the last subject across all sites is assessed or receives an intervention for evaluation in the study (ie, last subject last visit), following any additional parts in the study (eg, long-term follow-up), as applicable. |
La fecha de fin de estudio se define como la fecha en la que se evalúa el último sujeto en todos los centros o recibe la evaluación en el estudio (es decir, el último paciente de la última visita), siguiendo cualquier parte adicional del estudio (por ejemplo, seguimiento a largo plazo), según corresponda. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |